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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K253057
Device Name AI-Rad Companion Brain MR
Applicant
Siemens Healthcare GmbH
Henkestrasse 127
Erlangen,  DE 91052
Applicant Contact Kira Morales
Correspondent
Siemens Healthcare GmbH
Henkestrasse 127
Erlangen,  DE 91052
Correspondent Contact Kira Morales
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/22/2025
Decision Date 01/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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